Sweden has effectively blocked patient access to Leqembi, the first drug clinically shown to slow the progression of Alzheimer’s disease, after health authorities concluded its benefits were too limited to justify costs of up to €35,000 per patient annually.
The NT Council, which advises Sweden’s 21 regional health authorities on new treatments, recommended against hospital use of lecanemab – the drug’s active substance – despite its approval by the European Medicines Agency. The decision means the drug will not be covered under Sweden’s publicly funded healthcare system.
The Council’s chair, Mårten Lindström, acknowledged the urgency of finding effective Alzheimer’s treatments but said Leqembi offered “very limited and uncertain benefits” while carrying a risk of serious side effects, including brain microbleeds. Its administration – as a hospital infusion under medical supervision, with mandatory MRI monitoring – added further strain on already stretched resources, he said.
The negative recommendation follows a health economic assessment by the Dental and Pharmaceutical Benefits Agency, which found treatment and follow-up costs disproportionate to clinical gains. The ruling underlines a growing tension across Europe between regulatory approval of high-cost specialist drugs and the willingness of national payers to fund them.
Leqembi was granted marketing authorisation in the EU in April 2025 for adults with early-stage or mild Alzheimer’s disease who meet specific genetic criteria. In Sweden, this equates to around 3,500 individuals per year, according to TLV.
Regional cost burden
Before the recommendation was issued, negotiations had been held between the Swedish regions and the company Bioarctic to reduce the regions’ costs. However, according to the NT Council, the talks did not yield sufficient cost reductions.
The council also said it may be open to revising its decision after the EMA has reviewed a new market authorisation for a maintenance dose regimen that involves fewer infusions after 18 months of patient use, thereby lowering costs.
A green light in the future could still imply limitations, Lindström told Euractiv. “Significant resources will need to be allocated within the healthcare system, for example, for diagnostics and follow-up. If the criteria for its introduction are met, the healthcare system will likely need to set priorities.”
No choice for patients
The expert committee’s recommendation has sparked reactions from the Swedish Alzheimer’s Foundation and Bioarctic.
“I am deeply disappointed and saddened on behalf of Swedish patients. In practice, the NT Council’s decision means that people with early-onset Alzheimer’s disease continue to lack access to disease-modifying treatment, even though it is now available, Liselotte Jansson, Secretary General of the foundation, said.
Oskar Bosson, Bioractic’s VP and Head of IR and Communications, told Euractiv that the NT Council is questioning its efficacy, ”even though the drug has been approved by the EMA and there are now data showing significant benefits for patients who have been using Leqembi for four years.”
Mårten Lindström then countered: “The NT Council’s role is to assess the efficacy and health benefits in relation to the resources that would be required in the healthcare system if the medicine were to be introduced.”
However, 35 doctors criticised the public healthcare system’s refusal to use the drug, in an opinion piece in the newspaper Dagens Nyheter.
“We’re not saying that lecanemab is a miracle drug. Its effect is modest at the stages of the disease where it is currently used. But it is a drug that slows the progression of the disease. That is what our patients are asking for. That is what their families are hoping for,” they wrote.
The monoclonal antibody was discovered in 2003 and was subsequently further developed by the Japanese pharmaceutical giant Eisai in partnership with Bioarctic, which also entered into a collaboration with the US-based company Biogen.
According to Oskar Bosson, the drug is currently being reimbursed in Germany and Austria, while negotiations are ongoing regarding reimbursement in other EU countries.
[VA, BM]
Source:
www.euractiv.com